Abbott Laboratories: Medical Device Recall in 2023 - (Recall #: Z-0604-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number 08H00-01. Multi-parameter, automated hematology analyzer.

Product Classification:

Class II

Date Initiated: October 19, 2023

Date Posted: December 27, 2023

Recall Number: Z-0604-2024

Event ID: 93349

Reason for Recall:

The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).

Status: Ongoing

Product Quantity: 670 devices (329 US and 341 OUS)

Code Information:

All serial numbers are involved. CELL-DYN Ruby - UDI/DI 00380740017170; CELL-DYN Sapphire - UDI/DI 00380740016616.

Distribution Pattern:

Distribution was made to AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY, including Puerto Rico. There was also government and military distribution. Foreign distribution was made to Brazil.

Voluntary or Mandated:

Voluntary: Firm initiated